The invention relates to human cosmetic and reconstructive breast surgery. More specifically, the invention relates to pectoral pad breast implant medical devices, a measurement system, and a method of manufacturing and a method of use of the implant devices.
Breast implant devices are implanted under the breast tissue or under the chest muscle to increase breast size (augmentation) or to rebuild breast tissue after mastectomy (reconstruction). They are also used in revision surgeries, which correct or improve the shape and size of an original surgery or treat complications. Breast implants are additionally used in breast lift surgery.
A breast implant device is manufactured as an outer shell of silicone elastomer (rubber) distended with a fill material that can be either sterile saline solution or silicone gel (for example, fourth generation soft silicone or fifth generation form-stable silicone gel).
Current breast implants can be round-shaped or teardrop-shaped, saline-filled or silicone gel-filled, and they come in many combinations of width, profile, length and volume.
Implant shape is the single most important determinant of how the breasts look after augmentation or reconstruction surgery.
The implant shape is determined by the configuration of the mandrel (form, mold, or mandril) used to manufacture the shell. The mandrel is specifically constructed to create an implant having specific physical characteristics. Round-shaped implants are designed as a compressed sphere and teardrop implants mimic a “mature breast” with volume concentration at the lower part and deficient upper part. Hence, both round- and teardrop-shaped designs are constructed on the physical characteristics of a sphere.
Breast augmentation and reconstruction surgery aims to restore the breast's volume and shape that may have been lost due to weight loss, lactation, or aging that leave the breast envelop empty and saggy. Breast augmentation addresses the following most common concerns: lack of upper pole fullness of the breast, lack of projection of the breast, not enough cleavage, and small breasts disproportionately balanced to the overall figure of a patient.
Studies conducted by breast implant manufacturers under the supervision of regulatory agencies have shown that there are a multitude of common complications that leaves patients unhappy with artificial looking breasts, leading to high incidence of revision surgeries to correct the complications or even to remove the implants without replacement. These complications do not spare even celebrities. Certain defects are shown in the following figures:
FIG. 1 demonstrates wrinkled implant edge 1.
FIG. 2 demonstrates visible implant edges 2, and wide medial cleavage 3.
FIG. 3 demonstrates a round-shaped breast implant surgically placed behind the breast tissue to demonstrate bulging breast upper pole, with contour break and a step-off transition to the upper chest as a result of using round-shaped implant 4.
FIG. 4 demonstrates a teardrop-shaped breast implant surgically placed behind the breast tissue to demonstrate deficient breast upper pole as a result of using teardrop-shaped implant 5.
FIG. 5 demonstrates a round-shaped breast implant placed on a surface.
FIG. 6 demonstrates a teardrop-shaped implant placed on a surface.
Many surgeons remain uncomfortable with using teardrop-shaped cohesive-gel textured implants. As such, the main alternative is the traditional round-shaped breast implant.
The market share of teardrop implants is 12.7% of 2955 augmentation cases and 12.3% of 551 reconstruction patients according to one study. Therefore, there is a need for an implant that reduces complications, improves outcomes, and does not require extra technical needs in the hands of all surgeons
Fault in Current Implant Design
It is important to diagnose the roots of the above-described complications to understand if the complications are the result of faulty implant designs.
FIGS. 3-6 inclusive, demonstrates the multiple faults built in the current implant shape, including:
A. U-shaped thick edges 6 that are visible and palpable. As shown in FIG. 5, the ratio of the thickness of implant projection (profile) (arrow PP) to the edge (arrow UU) in round implants is ½, and in teardrop implant is ⅓. Camouflaging this edge is the primary concern of many surgeons. The present solution is to provide thick tissue coverage by placing the implant under the pectoralis major muscle, injecting homologues fat, or injecting acellular dermal matrix. These solutions help, but do not overcome the problem; hence many women request replacement or removal of the implant.
B. As shown in FIGS. 3 and 6, a convex implant footprint 7 is lying on a concave chest wall 8 and the implant is diverging away from the underlying surface in an angle 9 resulting in a dead space incorporated between the two surfaces, which will eventually become fibrosed, distorting the breast upper pole. In form-stable hard teardrop implants the convex footprint will facilitate rotation, distorting the shape of the breast and creating a major problem that needs revision surgery.
C. Geometric restrictions on implants being sufficiently tall: in a sphere, there is a constant association between volume, width, and height. When a round implant is made taller, it also becomes wider. Often it is wider than what can be accommodated by the breast base. When teardrop implants become taller, they become too narrow to fill the breast from side to side. State-of-the-art teardrop implants are often only be 0.5-1 cm taller than wide as shown in Table 1.
TABLE 1Dimensions of the state-of-art breast implants with adifference between the width and vertical height of 0.5-1 centimeters.WidthHeightDifferenceBreast implant style(cm)(cm)(cm)Allergan Natrelle ® 410FF9.5-15.510-160.5(Full height full projection)Mentor MemoryShape ® CPG ™  9-51.5 9.2-15.90.2-0.4Cohesive II, tall height, moderateprojectionSientra HSC+ classic base, moderate9.5-13  10.5-14  1  profileEurosilicone The Matrix9.5-15.510-160.5TMF1, TMF2, TMF3 full height
D. Referring again to FIGS. 3, 4 and 6, the “center of gravity” 10 of the implant 11 is situated a large distance TT from the chest wall resulting in strong gravitational pull on the implant leading to implant ptosis.
E. The implant footprint does not match the breast footprint, as shown in FIG. 7, where the current teardrop-shaped implant footprints are classic (round) R, oval O with a width bigger than the height, or tall T, while the breast footprint is paraboloid, as will be described later.
The current method of manufacturing a teardrop breast implant is shown in FIG. 8, where a teardrop shaped mandril M is inserted to a rotating machine via its handle H.
Similar complications and design problems involve implants used to augment or replace the gluteal area (buttock), facial check, calf, testes, and other body parts. Therefore, it would be beneficial to design an implant that overcomes these design flaws.